Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

Microcephaly Clinical Trial

Official title:

Guangzhou Surveillance and Clinical Study in Microcephaly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03651687
• Other study ID #: 2016111865-2
• Secondary ID: 81673181
• Status: Recruiting
• Start date: February 10, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Guangzhou Women and Children's Medical Center
• Contact: Xiu Qiu, MD,PhD
• Phone: 0086 20 38367160
• Email: qxiu0161[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Screening for microcephaly is important at birth and during early childhood. The Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM) aims to establish a multicentric surveillance system for microcephaly in newborns and infants, to develop a new head circumference reference and microcephaly criteria basing on the local population in Guangzhou, to improve the prediction model of microcephaly, and to follow up the outcomes of the children diagnosed with microcephaly.

Description:

Microcephaly is associated with neurological dysfunctions in infants and children. There is not a uniform diagnostic criteria for microcephaly. The World Health Organization (WHO) recommended a criteria of head circumference (HC) less than 2 standard deviations (SD) below the mean of the Intergrowth-21 standard, which was found not applicable to the newborns and infants in Guangzhou.In the GSCSM, the HC measures of newborns are conducted by trained midwives using a standard tool, and extensive information including adverse perinatal outcomes are collected. Longitudinal follow up of infants' neurodevelopment in cognitive, motor, emotional and other domains are also to be conducted. The GSCSM intends to find out the infants who are 'real microcephaly' and most at risk of short-term or long-term adverse outcomes in Guangzhou.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

1. Newborns born after 24+0 weeks of gestation

2. Newborns delivered at the study hospitals

Exclusion Criteria:

1. With major congenital abnormalities

2. Multiple births

Related Conditions & MeSH terms

• Microcephaly

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center, China	Guangzhou

Sponsors (4)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center	Guangzhou Huadu Women and Children Health Care Hospital, Guangzhou Liwan Women and Children Health Care Hospital, Institut Pasteur

Country where clinical trial is conducted

China, 

References & Publications (1)

He JR, Li WD, Lu MS, Guo Y, Chan FF, Lu JH, Zhang LF, Shen SY, Xia XY, Wang P, Mo WJ, Lam KBH, Hirst JE, Xia HM, Qiu X. Birth weight changes in a major city under rapid socioeconomic transition in China. Sci Rep. 2017 Apr 21;7(1):1031. doi: 10.1038/s41598-017-01068-w. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of microcephaly	Assessed by the head circumference measured using a standard tool	At birth
Secondary	Neurodevelopmental performance of children	Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules or Ages and Stages Questionnaire	At birth, 6 weeks, 6 months, 1 year and 2 years
Secondary	Head circumference changes of children	Head circumference changes from birth to infancy (catch-up or drop)	At birth, 6 weeks, 6 months, 1 year to 2 years